Yakima Head Start Fluoride Varnish Study
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|ClinicalTrials.gov Identifier: NCT00067353|
Recruitment Status : Completed
First Posted : August 19, 2003
Last Update Posted : May 10, 2010
|Condition or disease||Intervention/treatment||Phase|
|Dental Caries||Drug: Fluoride varnish||Phase 3|
The study population will consist of pre-school aged children who are residents of Yakima County, in central Washington State. Children will be recruited from non-migrant Head Start programs for ethnic minority farmworker children in the Yakima Valley.
This study will be a randomized, double blinded trial with one experimental and one standard treatment group. Each participant will be randomly assigned to one of two study groups. The participant and the personnel conducting the study will not know to which study group the participant was assigned.
This trial has two study groups:
Massive Dose (Experimental):
Annually for three years, children in the experimental group will receive three .30ml applications of 50mg NaF/mL fluoride varnish (CavityShieldÒ, Omni), followed 6 months later by three .30ml applications of placebo varnish in two weeks. There are 18 visits over the entire duration of the study. Each participant will receive a dental exam annually.
- Semiannual Dose (Standard):
Annually for three years, children in the standard treatment group will receive one .30ml application of 50mg NaF/mL fluoride varnish (CavityShieldÒ, Omni) and two .30ml applications of placebo varnish in two weeks. They will receive this regimen again 6 months later. There are 18 visits over the entire duration of the study. Each participant will receive a dental exam annually.
Both the experimental and standard treatment children will receive basic restorative dental care on decayed surfaces only, as well as toothbrushes for the duration of the study period. Parents will fill out questionnaires about behaviors such as diet, hygiene and prior dental care. Results will inform future treatment regimens for high-caries-risk populations.
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||500 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Fluoride Varnish Trial in High Caries Preschoolers|
|Study Start Date :||November 2003|
|Actual Primary Completion Date :||July 2005|
|Actual Study Completion Date :||August 2005|
- Number of decayed, missing, or filled surfaces
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00067353
|United States, Washington|
|Enterprise for Progress in the Community (EPIC) Head Start sites|
|Lower Valley, Yakima County, Washington, United States, 98902|
|Washington State Migrant Council Head Start sites|
|Lower Valley, Yakima County, Washington, United States, 98944|
|Principal Investigator:||Philip Weinstein, DDS||Washington State Head Start Sites|